NCT02302586

Brief Summary

Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

November 20, 2014

Last Update Submit

August 2, 2017

Conditions

Pain, Postoperative

Keywords

Thoracic paravertebral blockPatient controlled analgesiaVideo Assisted Thoracoscopic SurgeryPostoperative acute painChronic pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative chronic pain scores (VAS) at rest and during mobilization

    Chronic pain follow-up

    Up to 6 months

Secondary Outcomes (8)

  • Postoperative vital signs

    0-48 hours

  • Postoperative acute pain at rest and during coughing/mobilization

    0-48 hours

  • Postoperative nausea and vomiting (PONV) and antiemetic requirements

    0-48 hours

  • Postoperative morphine consumption

    0-48 hours

  • Time to first analgesic

    0-48 hours

  • +3 more secondary outcomes

Study Arms (2)

Patient Controlled Analgesia (IV PCA)

ACTIVE COMPARATOR

Postoperative intravenous (IV) morphine PCA is being used for acute pain control: Basal infusion: 0.3 mg/kg/h Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg

Drug: Patient Controlled Analgesia (IV PCA)

Thoracic Paravertebral Block (TPVB)

ACTIVE COMPARATOR

Preoperative thoracic paravertebral block (TPVB) at 4 levels from T4 to T8 is being performed and total of 20 mL Bupivacaine 0.5% is deposited (5 mL per level by using landmark technique)

Drug: Thoracic paravertebral block (TPVB)

Interventions

Thoracic paravertebral block (TPVB)DRUG

Thoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique

Also known as: Bupivacaine
Thoracic Paravertebral Block (TPVB)
Patient Controlled Analgesia (IV PCA)DRUG

IV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg

Also known as: Morphine
Patient Controlled Analgesia (IV PCA)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA

You may not qualify if:

  • Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • Komatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1.

    PMID: 25091399BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Interventions

BupivacaineAnalgesia, Patient-ControlledMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnalgesiaAnesthesia and AnalgesiaMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Mert N Senturk, Prof

    MD, Prof

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Prof. Dr

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 27, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)